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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K950652
Device Name OSTEOTECH NAVICULAR AND CANCELLOUS CANNULATED SCREWS
Applicant
Osteotech, Inc.
1151 Shrewsbury Ave.
Shrewsbury,  NJ  07702
Applicant Contact CJRISTOPHER TALBOT
Correspondent
Osteotech, Inc.
1151 Shrewsbury Ave.
Shrewsbury,  NJ  07702
Correspondent Contact CJRISTOPHER TALBOT
Regulation Number888.3040
Classification Product Code
HWC  
Date Received02/13/1995
Decision Date 06/22/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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